| 引用本文: | 陈林,赵培敬.螺内酯片有关物质检测方法的优化[J].中国现代应用药学,2023,40(1):112-115. |
| CHEN Lin,ZHAO Pei-jing.Improvement of Determination Method for Related Substance in Spironolactone Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(1):112-115. |
|
| 摘要: |
| 目的 优化螺内酯片有关物质的测定方法和供试品溶液制备方法。方法 采用Welch Materials Eclipse XB-C18色谱柱(4.6mm×250mm,5μm),以乙腈-水(54∶46)为流动相,流速1.0mL·min-1,检测波长254nm和283nm,柱温35℃。样品以流动相为提取溶剂,超声提取。结果 主峰与各杂质峰均能良好分离。螺内酯、坎利酮分别在1.00~100.38,1.03~102.53μg·mL-1内线性关系良好(r均为1.000),回收率分别为99.52%和99.23%。结论 本方法结果准确、重复性好、专属性强,比中国药典方法操作更简便,可为螺内酯片有关物质检测方法的优化提供参考依据。 |
| 关键词: 螺内酯片 有关物质检测 优化 |
| DOI：10.13748/j.cnki.issn1007-7693.2023.01.015 |
| 分类号:R917 |
| 基金项目: |
|
| Improvement of Determination Method for Related Substance in Spironolactone Tablets |
|
CHEN Lin, ZHAO Pei-jing
|
|
Nanyang Institute for Food and Drug Control, Nanyang 473061, China
|
| Abstract: |
| OBJECTIVE To improve the method for related substance determination and sample preparation of spironolactone tablets.METHODS The detection method was performed on the column of Welch Materials Eclipse XB-C18column(4.6 mm×250 mm,5μm) with mobile phase of acetonitrile-water(54∶46) at flow rate of 1.0 mL·min-1,detection wavelengths was 254 nm and 283 nm,column temperature was 35℃.The samples were extracted by flow phase ultrasonic method.RESULTS Related substances were completely separated from the principal component.The linear range of spironolactone and canrenone were 1.00-100.38μg·mL-1 and 1.03-102.53μg·mL-1(r=1.000),respectively.The average recovery rates were 99.52%and 99.23%,respectively.CONCLUSION The method is simple,accurate,reproducible and more convenient than the Chinese Pharmacopoeia method,which can provide reference for the optimization of the determination method of spironolactone tablets in the future. |
| Key words: spironolactone tablets related substance determination improvement |
